Safe and Effective Medicines for Children Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (2012) / Chapter Skim
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Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA
Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA
Pages 271-284
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, pharmacology, safety, and supporting studies. However, the drug label frequently contains little pediatric prescribing information.
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It describes intermediary resources that include, to various degrees, any information from the FDA label that provides guidance on prescribing medications for children. PEDIATRIC USE AND PEDIATRIC LABELING Many medications used by children are not specifically approved by FDA for such use.
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Few labeling changes have included infant-specific information. Infants and premature infants represented only 0.2 and 0.01 percent, respectively, of all children studied in trials submitted to FDA through the pediatric exclusivity program from 1998 to 2005.2 Notwithstanding the benefits of the FDA process for approving drugs and authorizing information in the product's labeling, the question about whether and how this information reaches physicians and how it influences clinical practice remains.
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Update of the American Academy of Pediatrics on new dosing, safety, and efficacy findings. FDA has also published a number of articles focusing on findings from pediatric trials stimulated by BPCA and PREA.6,13,14,28–32 FDA's Office of Pediatric Therapeutics has made efforts to work directly with the editors of The Harriet Lane Handbook, commonly used by pediatricians, to update dosing information.
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SOURCE: Authors' survey of neonatologists and neonatal nurse practitioners em ployed by the Pediatrix Medical Group, Inc., in 278 neonatal intensive care units. Figure B-1.eps
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and at Duke University Medical Center about whether they had consulted a drug label for pediatric dosing guidance. None of the 40 clinicians reported that they had read an FDA label or used the FDA label to obtain prescribing information.
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Directed toward micromedex.com hospital formularies PDR Network, www.pdr.net Uses FDA Physicians' Desk Reference38,39 label as source Red Book American Academy of Pediatrics, Free to AAP www.aap.org members American Academy of Pediatrics, Free to AAP Nelson's www.aap.org members Pocket Book of Pediatric Antimicrobial Therapy40 Tarascon Publishing, www. Limited pediatric Tarascon Pharmacopoeia41 tarascon.com data Medscape/ www.medscape.com, www.
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From page 278... ...
subscription, findings difficult to interpret NAa Pharmacy Fast Bias consultation38 Experience38 NA Fast, efficient Bias Local pharmacy NA Fast Uncertain how computer dosing information physician order is derived entry pharmacy systems (e.g., Sunrise Clinical Manager38) Subspecialist http://www.guideline.gov/, other Bias guidelines subspecialty sites (e.g., pediatric infectious disease, pediatric gastroenterology)
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From page 279... ...
The two most commonly used are The Harriet Lane Handbook36 for pediatricians and Neofax for providers working in the neonatal intensive care unit. The Harriet Lane Handbook and Neofax use the FDA labels as a guideline and periodically update (usually every 1 to 2 years)
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In general, analyses demonstrate a wide variability in the effectiveness of clinical decision support tools.54,55 For example, in a large national health plan, physicians who had access to a handheld electronic formulary (Epocrates) had similar patterns of prescribing nongeneric, nonformulary medications, compared to the prescribing patterns of those physicians without access to such a device.54 EXTENT TO WHICH LABELING CHANGES ARE REFLECTED IN RESOURCES A systematic investigation of the extent to which information resources are updated in a timely and accurate way to reflect drug labeling changes was beyond the scope of this paper.
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Neither The Harriet Lane Handbook nor Neofax routinely notes when dosing is recommended for off-label indications or age groups.35,36,48 Neofax does, however, provide references for its dosing recommendations.35
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Although FDA rigorously reviews the accuracy and completeness of drug labeling proposed by sponsors and revisions to proposed language are common, this paper suggests that the extent to which providers directly use labels is limited. Instead, clinicians who prescribe medication to children rely upon intermediary resources that come in various printed or online forms.
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Economic return of clinical trials performed under the pediatric exclusivity program.
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Drug utilization in the pediatric intensive care unit: monitoring prescribing trends and establishing prioritization of pharmaco therapeutic evaluation of critically ill children. J Clin Pharmacol 2005;45:1305-12.
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